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510(k) K896540

ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE by Nuclear Data Systems — Product Code IZD

K896540 is an FDA 510(k) premarket notification submitted by Nuclear Data Systems for the device "ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE". The FDA issued a decision of Substantially Equivalent on April 19, 1990. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Nuclear Data Systems has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1990
Date Received
November 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Uptake, Nuclear
Device Class
Class I
Regulation Number
892.1320
Review Panel
RA
Submission Type

Other clearances by Nuclear Data Systems

  • K925650 — IMAGEVIEW 5000 (September 14, 1993)

Other clearances for product code IZD

  • K133781 — DECLIPSESPECT LAPAROSCOPY (April 11, 2014)
  • K123917 — DECLIPSESPECT VIEWER (January 25, 2013)
  • K101887 — CONFIDENT SURGERY SUITE 300, MODEL CSS300 (March 22, 2011)
  • K013751 — HANDHELD GAMMA FINDER (HGF) (February 6, 2002)
  • K983768 — MODIFICATION TO GAMMA GUIDANCE SYSTEM (July 2, 1999)
  • K982442 — C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (August 25, 1998)
  • K971167 — NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (June 26, 1997)
  • K961321 — GAMMA GUIDANCE SYSTEM (February 10, 1997)
  • K962319 — NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (September 13, 1996)
  • K942580 — NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (February 9, 1995)

FDA data resources